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Clinical effects and economical impact of dutasteride and finasteride therapy in Italian men with LUTS

Luca Cindolo, Francesco Berardinelli, Caterina Fanizza, Marilena Romero, Luisella Pirozzi, Fabiola Raffaella Tamburro, Fabrizio Pellegrini, Fabio Neri, Andrea Pitrelli, Luigi Schips
  • Francesco Berardinelli
    S. Pio da Pietrelcina Hospital, Dept. of Urology, Vasto, Italy
  • Caterina Fanizza
    Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy
  • Marilena Romero
    Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy
  • Luisella Pirozzi
    Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro, Italy
  • Fabiola Raffaella Tamburro
    S. Pio da Pietrelcina Hospital, Dept. of Urology, Vasto, Italy
  • Fabrizio Pellegrini
    S. Pio da Pietrelcina Hospital, Dept. of Urology, Vasto, Italy
  • Fabio Neri
    S. Pio da Pietrelcina Hospital, Dept. of Urology, Vasto, Italy
  • Andrea Pitrelli
    Access to Medicine, GlaxoSmithKline spa, Verona, Taiwan, Province of China
  • Luigi Schips
    S. Pio da Pietrelcina Hospital, Dept. of Urology, Vasto, Italy

Abstract

Objectives: To investigate differences in the risk of benign prostatic hyperplasia (BPH)- related hospitalization, for surgical and non-surgical reasons, and of new prostate cancer (PCa) diagnosis between patients under dutasteride or finasteride treatment. Material and methods: A retrospective cohort study was conducted using data from record-linkage of administrative databases. Men aged ≥ 40 years old who had received a prescription for at least 10 boxes/year (index years: 2004-06) were included. The association of the outcomes was assessed using a multiple Cox proportional hazard model. Propensity scorematched analysis and a 5-to-1, greedy 1:1 matching algorithm were performed. The budget impact analysis of dutasteride vs finasteride in BPH-treated patient was performed. Results: From an initial cohort of about 1.5 million of Italian men, 19620 were selected. The overall hospitalization for BPH-non surgical reasons, for BPH-related surgery and for new detection of PCa incidence rates (IRs) were 8.20 (95% CI, 7.62-8.23), 18.0 (95% CI, 17.12-18.93) and 8.62 (95% CI, 8.03-9.26) per 1000 person-years, respectively. The multivariate analysis after the propensity score-matching showed that dutasteride was associated with an independent reduced likelihood of hospitalization for BPH-related surgery (HR 0.82; 95% CI 0.73-0.93; p = 0.0025) and of newly detected PCa (HR: 0.76,95% CI, 0.65-0.85; p = 0.0116). The IR for BPH-non surgical reasons was 8.07 (95% CI, 7.10-9.17) and 9.25 (95% CI, 8.19-10.44) per 1000 person-years, respectively. The IR for BPH-related surgery was 18.28 (95% CI, 17.17-20.32) and 21.28 (95% CI, 19.24-23.06) per 1000 person-years among patients under dutasteride compared with those under finasteride, respectively. For new-onset PCa, the IR was 8.01 (95% CI, 7.07-9.08) and 9.38 (95% CI, 8.32-10.58) per 1000 person-years The pharmacoeconomical evaluation showed that the net budget impact of the use of dutasteride vs. finasteride in 1000 BPH-treated patient for 1 year induces a saving of 3933 €. Conclusions: The clinical effects of dutasteride and finasteride are slightly different. The likelihood of hospitalization for BPH-related surgery and of newly detected PCa seems to be in favor of dutasteride. The budget impact analyses showed a slightly benefit for dutasteride. Comparative prospective studies are necessary to confirm these results.

Keywords

Benign prostatic hyperplasia (BPH); Dutasteride; Finasteride; Epidemiology; Medical record-linkage

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Submitted: 2014-01-02 16:36:27
Published: 2013-12-31 00:00:00
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Copyright (c) 2013 Luca Cindolo, Francesco Berardinelli, Caterina Fanizza, Marilena Romero, Luisella Pirozzi, Fabiola Raffaella Tamburro, Fabrizio Pellegrini, Fabio Neri, Andrea Pitrelli, Luigi Schips

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